NCT03090594

Brief Summary

Cryobiopsy has displaced the transbronchial biopsy (BTB) with forceps because it allows to obtain samples of more representative pulmonary parenchyma with more alveoli, less artifacts and a greater diagnostic yield. However, some authors report an increase in adverse effects such as hemorrhage and pneumothorax. The latest ISHLT (International Society for Heart and Lung Transplantation) consensus of 2007 recommends that with BTB with forceps a minimum of five tissue samples should be obtained that should contain more than 100 wells or the presence of two bronchioles to Which may be necessary between 3 and 17 samples. The optimal number of transbronchial cryobiopsies is unknown in order to obtain maximum performance with the lowest possible morbidity. It is proposed to analyze the morphological and histopathological characteristics of each cryobiopsies individually and in order of extraction, to determine the sensitivity in the diagnosis of acute rejection as a function of the number of samples. Lung transplant patients, not admitted to critical units, with BTB indication will be included. A maximum of 6 samples will be obtained by flexible bronchoscope and under general anesthesia. These data will allow to know the minimum number of specimens that guarantee a histological and / or bacteriological diagnosis of certainty with maximum effectiveness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

March 14, 2017

Last Update Submit

March 20, 2017

Conditions

Lung Transplantation

Keywords

CryoprobeBronchoscopyAcute cellular rejection

Outcome Measures

Primary Outcomes (1)

  • Number of transbronchial biopsies with which a pathological diagnosis is obtained. The rejection graduation according to the criteria of the International Society for Heart Lung Transplantation (ISHLT).

    A maximum of 6 samples will be obtained.

    5-7 days.

Secondary Outcomes (2)

  • Number of alveoli, bronchi, bronchioles, blood vessels and pleura containing each biopsy.

    30 days.

  • Number of complications related to the procedure.

    30 days.

Study Arms (1)

Biopsy

OTHER

Transbronchial biopsies with cryoprobe.

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary transplant patients with suspected rejection or infection requiring transbronchial biopsy

You may not qualify if:

  • Respiratory failure refractory to oxygen therapy.
  • Acute or subacute ischemic heart disease (last 4-6 weeks).
  • Severe arrhythmias.
  • Coagulation disorders: platelets \<60,000-50,000 or Prothrombin time \<60%.
  • Lack of consent informed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall de Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Javier De Gracia, MD PhD

    Respiratory department.

    PRINCIPAL INVESTIGATOR

  • Karina Loor, MD

    Respiratory department.

    STUDY CHAIR

  • Mario Culebras, MD

    Respiratory department.

    STUDY CHAIR

  • Antonio Álvarez, MD

    Respiratory department.

    STUDY CHAIR

Central Study Contacts

Karina Loor, MD

CONTACT

93 274 6138kloor@vhebron.net

Javier De Gracia, MD PhD

CONTACT

93 274 6138jgracia.jgracia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 27, 2017

Study Start

March 14, 2017

Primary Completion

September 17, 2017

Study Completion

March 1, 2018

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)